280
- St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrex-
ate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum.
2004;50:3432–43. - Food & Drug Administration.Scientific considerations in demonstrating biosimi-
larity to a reference product: guidance fo industry. http://www.fda.gov/downloads/
DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.Last updated
April 2015. - World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Productions
(SBPs).http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_
FOR_WEB_22APRIL2010.pdf.Last updated October 2009. - Demonstrate noninferiority in efficacy and to assess safety of CT-P13 in patients with active
Crohn’s disease. https://clinicaltrials.gov/ct2/show/NCT02096861?term=CT-P13&rank=1. - Efficacy and Safety of Infliximab-biosimilar (inflectra) compared to infliximab-innovator
(remicade) in patients with inflammatory bowel disease in remission: the SIMILAR trial.
https://clinicaltrials.gov/ct2/show/NCT02452151?term=02452151&rank=1. - Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Berset IP, et al. Dop062
Biosimilar infliximab (ct-p13) is not inferior to originator infliximab: explorative Ibd sub-
group-analyses in Crohn’s disease and ulcerative colitis from the Nor-switch trial. J Crohns
Colitis. 2017;11(suppl_1):S62–3. - Mitoma H, Horiuchi T, Tsukamoto H, et al. Mechanisms for cytotoxic effects of anti-tumor
necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: com-
parison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008;58:1248–57. - Tilg H, Moschen A, Kaser A. Mode of function of biological anti-TNF agents in the treatment
of inflammatory bowel diseases. Expert Opin Biol Ther. 2007;7:1051–9. - Horiuchi T, Mitoma H, Harashima S, et al. Transmembrane TNF-alpha: structure, function and
interaction with anti-TNF agents. Rheumatology (Oxford). 2010;49:1215–28. - Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination ther-
apy for Crohn’s disease. N Engl J Med. 2010;362:1383–95. - Feagan BG, McDonald JW, Panaccione R, et al. Methotrexate in combination with infliximab
is no more effective than infliximab alone in patients with Crohn’s disease. Gastroenterology.
2014;146:681–688 e1. - Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and aza-
thioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology.
2014;146:392–400e3. - Feagan BG, Choquette D, Ghosh S, et al. The challenge of indication extrapolation for inflix-
imab biosimilars. Biologicals. 2014;42:177–83. - Mertens M, Singh JA. Anakinra for rheumatoid arthritis: a systematic review. J Rheumatol.
2009;36:1118–25. - Keating GM. Abatacept: a review of its use in the management of rheumatoid arthritis. Drugs.
2013;73:1095–119. - Mok CC. Rituximab for the treatment of rheumatoid arthritis: an update. Drug Des Devel Ther.
2014;8:87–100. - Kaser A. Not all monoclonals are created equal - lessons from failed drug trials in Crohn’s
disease. Best Pract Res Clin Gastroenterol. 2014;28:437–49. - Summary Basis of Decision (SBD): Inflectra—2014—Heatlh Canada. http://www.hc-sc.
gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_inflectra_159493-eng.php
Last updated 11/23/15. - European medicines agency assessment report: remsima.http://www.ema.europa.eu/docs/en_
GB/documentlibrary/EPAR-_Public_assessment_report/human/002576/WC500151486.pdf.. - Food & Drug Administration. FDA approves Inflectra, a biosimilar to Remicade.http://www.
fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. - Food & Drug Administration. Considerations in demonstrating interchangeability
with a reference product: guidance for industry. http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed Feb 2017.
C.Y. Ha and A. Kornbluth